JP2022506466A - Devices, systems, and methods for the treatment of neurogenic bladder - Google Patents

Abstract

Embodiments of the invention provide devices, systems, and methods for stimulating tissues in the urinary tract to initiate or promote urination. One embodiment provides an external urethral sphincter stimulation (EUSS) catheter for stimulating the external urethral sphincter (EUS), which is a nerve in or around the EUS to relax the EUS prior to urination. Includes a nerve stimulating electrode (NSES) for delivering current to the urethral sphincter. Another embodiment provides a system for stimulating an EUS, comprising an EUSS catheter and a controller operably coupled to the USES catheter, the controller for delivering a current to the NSES. including. Another embodiment provides a method for positioning an EUSS catheter within the patient's body, including within the EUS, using a urethral approach.

Description

(Mutual reference of related applications)
This application claims the interests and priority of US Provisional Patent Application No. 62 / 754,433, filed November 1, 2018, which is incorporated herein by reference in its entirety for any purpose. do.

1. 1. INDUSTRIAL APPLICABILITY The present invention relates to a system and a method for treating a patient who has lost the ability to spontaneously control one or more physical functions such as urination due to spinal cord injury or other neuropathy. More specifically, embodiments of the present invention relate to systems and methods for treating such patients via electrical stimulation of one or more tissue sites associated with the control of urination. Still more specifically, embodiments relate to systems and methods for treating such patients via electrical stimulation of the external urethral sphincter.

Nerves and other nervous tissues in the body control how the bladder stores and drains urine. These nerve damage can result in conditions known as neurogenic bladder (also known as neurogenic bladder dysfunction), characterized by bladder dysfunction, including loss of bladder control. Conditions can be caused by nerve damage or injury from the spinal cord that innervates or signals the brain, or spinal cord, or organs in the urinary tract such as the sacral and pudendal nerves. Such nerve injuries are the result of spinal cord injuries (eg, from falls, car accidents, or war injuries) or diseases such as multiple sclerosis (MS), Parkinson's disease, or diabetes. It can also be caused by a brain or spinal cord infection, heavy metal poisoning, stroke, spinal cord injury, or major pelvic surgery. Symptoms of neurogenic bladder may include overactive bladder (OAB), underactive bladder (UAB), incontinence (including urgent incontinence), and / or obstructive bladder in which urinary flow is blocked.

Most commonly, patients suffering from spinal cord injuries may lose not only the ability to spontaneously control urination, but also the ability to sense when the bladder is full. Such patients needed to rely on chronic use of urinary catheters, which are usually placed through the urethra and have a distal tip that resides within the bladder. Such Foley catheters present a certain risk of infection, which is exacerbated by the frequent need to replace a clogged catheter with a new one. In addition, Foley catheters are typically drained into a bag that the patient must carry when away from home or treatment facility. The need to carry a drain bag is a heavy burden for many patients.

Allows patients and their caregivers to selectively stimulate the pudendal nerves to control bladder excretion, at least in part, to overcome the above problems in treating neurogenic bladder. A very promising new system has been proposed. Such a system can eliminate the need for a Foley catheter, eg, US Patent Publication No. 2014/0249595 (all disclosures thereof are incorporated herein by reference for all purposes). It is explained in.

Although a major advance, such pudendal nerve stimulation systems require surgical implantation of stimulating electrodes in the vicinity of the pudendal nerve, typically performed by access through the patient's buttocks. There are some drawbacks to such an approach. First, the procedure is highly invasive and, when performed in the buttock area, results in the patient becoming incapacitated over a long cycle, with the risk of exacerbated surgical infections. Also, the pudendal nerve can be difficult to locate in the surgical field via the buttock approach. Moreover, such surgery is not always successful. In particular, the electrodes may dislodge or cause nerve damage and require removal and / or replacement surgery.

For these reasons, we provide improved systems and methods for initiating and controlling urination through stimulation of tissues other than the pudendal nerve, and / or do so using a less invasive approach. Would be desirable. It would be further desirable to provide devices, devices, and systems suitable for minimally invasive implantation, and methods for positioning and implanting such systems. At least some of these objectives will be met by the invention described below.

2. 2. Description of Background Techniques US 2014/0249595 has been described above. See also US 2014/0058284, US 2014/0058588, US 2014/0309550, and US 2017/0203100.

U.S. Patent Publication No. 2014/0249595

Various embodiments of the present invention provide devices, systems, and methods for initiating and controlling body excretory functions such as urination and defecation. Many embodiments of the invention provide devices, systems, and methods for initiating and controlling urination via stimulation of various types of body tissues and structures such as nerves, muscles, sphincter muscles, and vascular tissues. .. Certain embodiments typically provide devices, systems, and methods for doing so by stimulating tissues other than the pudendal nerve. In addition, certain embodiments provide stimulation devices such as catheters or leads for stimulating tissues such as the external urethral sphincter (EUS) to initiate and / or control urination. Such devices, systems, and methods are particularly useful for the treatment of patients with neurogenic bladder who have lost the ability to spontaneously initiate and / or control urination.

In the first aspect, embodiments of the invention, hereinafter referred to as EUS stimulation or "EUSS" catheters, are stimulation to stimulate EUS and / or to control urination or other urinary function. Provide a catheter or other stimulating device. Other embodiments of the device (stimulation device or EUS stimulation device herein) also correspond to leads or other extension members having one or more features of the catheter described herein. good. EUSS catheters are located at the proximal end, the distal end, the proximal end, a mooring element (also called an anchor), at least one nerve stimulating electrode, and an electrical plug connector (electric connector, connector element, Also referred to as a connector) and a catheter body having a removable or otherwise removable distal portion having a tissue penetrating distal end. In various embodiments, the removable distal portion is configured to act as a tether for pulling a portion of the EUSS catheter through and / or out of the patient's tissue, and thus, from time to time, herein. In the book, it is referred to as the "distal tether portion," "distal tether," or simply "tether." Further, in a specific embodiment, the mooring element corresponds to the tip of the ball. The ball tip or other mooring element may include a polymer or a conductive metal such as platinum or stainless steel. When including conductive metal or other material, the ball tip or other mooring element is along the catheter body distal to the ball tip to provide a bipolar configuration of current delivery to the nerve stimulation electrode and EUS. It may be used as an electrode in combination with one or more positioned neurostimulatory electrodes.

The EUSS catheter advances into the patient's urethra, typically through the lumen of the induction catheter, then through the urethral wall and into the EUS using the tissue-penetrating end of the removable distal tether portion. It is configured to be. The induction catheter will typically have an induction lumen with an exit port oriented to laterally deflect the tissue penetration end of the nerve stimulation electrode. Thus, by properly axially rotating and positioning the inductive catheter within the urethra, the tissue-penetrating end of the distal tether portion of the EUSS catheter advances (eg, steered) towards the desired exit location within the urethra. ) Can be done.

Once the tissue penetrating end has passed through the urethral wall, both the catheter body and the distal portion of the EUSS catheter have the tissue penetrating end of the removable distal tether portion typically in the patient's perineal or gluteal area. Has sufficient column strength to push and advance the tissue penetrating end through the tissue until it exits through the surface of the external tissue (skin). The EUSS catheter is further retracted distally by a removable portion and is configured to have sufficient tensile (pulling) strength to place the ball tip in the EUS or surrounding tissue.

At least one nerve stimulating electrode is located on the catheter body near the proximal end and delivers the stimulating current to the EUS and / or to the nerves that innervate it, allowing urine to flow into the urethra. It is configured to relax the EUS sufficiently to allow it. The electrical plug connector is located near the distal end of the catheter body, is electrically coupled to at least one neurostimulation electrode, and is either implanted in the patient's body or outside. It is configured to be connected to any one of a controller, a pulse generator, or another electrical stimulator. The electrical connector advances into the tissue of the patient's buttock / perineal region (when the tissue penetration end is advanced through the patient's buttock / perineal region) and then into the subcutaneous tissue within the patient's back area. It is configured to be, where it (they) may be connected to a meshing connector for a pulse generator or other stimulator. In certain embodiments, the electrical connector on the catheter is a series of conductions, such as a conductive metal ring or strip, that is electrically coupled to each of the nerve stimulation electrodes by an extension conductor extending axially through the catheter body. It may have a sexual element. The extension conductor is typically a metal wire that contributes to the tensile strength of the catheter body. Optionally, the catheter body is also an advantage when the catheter body is pulled into a desired tissue location within the patient's body, such as anchoring the ball tip as described herein. It may be reinforced with aramid (eg, Kebra®) or other polymers or metal filaments to enhance the tensile strength of the catheter body. Specifically, such reinforcement is provided by its distal portion to provide sufficient tensile force to moor the ball tip or other anchor within the tissue, such as the EUS or other tissue site. Promotes the pulling of the catheter.

The removable distal or distal tether portion of the EUSS catheter is typically guided while the distal tether portion retains sufficient column strength for it to be advanced into the urethral wall tissue. A wire or tube containing nickel titanium (eg, Nitinol®) or other superelastic metal or similar metal that allows it to bend and bend as it is advanced outward from the lateral opening in the catheter. Will be equipped with. The tissue-penetrating end of the removable distal tether portion typically penetrates into the urethral wall as it is advanced into the EUS, and then exits the tissue in this area. It will be hardened to enhance penetration into or through the patient's gluteal or perineal area. Curing may be achieved through various metalworking methods known in the art or by varying one or more of the diameters or compositions of tissue penetration edges.

Once the tissue-penetrating end of the removable distal tether portion exits the skin surface, the doctor pulls on the distal end of the removable portion, and the ball tip or other mooring element enters the urethral wall and / Or retract the catheter body of the EUSS catheter through the urethral wall and thus stimulate the EUS and / or pudendal nerve (eg, from the pudendal nerve causing contraction of the EUS) until placed in or adjacent to the EUS. Stimulation electrodes can be properly placed to cause relaxation of the EUS (by blocking the signal of). The distal tether portion can then be removed from the catheter body by any one of the various removable mechanisms and / or means known in catheter and medical lead techniques. For example, the distal tether portion may be configured to be cut from the catheter body using conventional surgical cutting tools.

In an exemplary embodiment, the at least one nerve stimulating electrode comprises at least two nerve stimulating electrodes, the at least two nerve stimulating electrodes axially along the length of the EUSS catheter body distal to the proximal anchor. They may be separated. Alternatively, the first nerve stimulating electrode may be located on one side of the catheter body or the second nerve stimulating electrode may be located on the opposite side of the catheter body. Still in further embodiments, the at least one nerve stimulating electrode may include at least three nerve electrodes, and in some cases, at least one nerve stimulating electrode may include at least four nerve electrodes. Additional numbers are envisioned.

In an exemplary embodiment, the EUSS catheter comprises at least two stimulating electrodes, which will typically be configured to deliver a bipolar current to the EUS, but monopolar configurations will also be. Will be considered. The nerve stimulation electrodes may be positioned on various locations on the catheter body. For example, the first nerve stimulation electrode may be placed on one side of the catheter body, or the second nerve stimulation electrode may be placed on the opposite side of the catheter body. According to other embodiments, the electrodes may be axially spaced along the length of the EUSS catheter, for example, the first nerve stimulation electrode is located at the first axial location on the catheter body. Alternatively, the second nerve stimulation electrode may be located at a second axial location on the catheter body. Typically, such axially spaced electrodes will include, at least in part, a ring electrode that surrounds the catheter body. The width of the electrodes can be in the range of 1 to 3 mm and the spacing between the electrodes can be in the range of 1 to 5 mm. Other electrode shapes are also envisioned, including partial ring shapes (eg, semicircles) that can be distributed along the circumference of the EUS catheter body.

In a preferred embodiment, the EUS catheter body will include four or more rings or other forms of stimulation electrodes that are axially spaced along the length of the catheter or lead. All or selected numbers of electrodes may be energized in parallel and / or continuously in pairs to provide bipolar stimulation with current from a pulse generator or other current source. The number and spacing of the stimulation electrodes on the catheter can be configured to generate a selectable electric field volume within or adjacent to the EUS to stimulate and relax the EUS in response to energization of the stimulation electrodes. .. In a related embodiment, the number of electrodes energized with an electric current to stimulate the EUS can also be selected to generate the desired electric field volume within or adjacent to the EUS. In various embodiments, the choice of stimulation electrode to be energized is operably coupled to an EUS stimulation catheter and pulse generator or other current generating means, the controller (or other logical resource) described herein. ) May be implemented.

In a specific case, the mooring element may have a ball shape with a diameter greater than the diameter of the proximal end of the catheter body. Further, in a specific case, the mooring element is itself conductive and is configured to act as a nerve stimulating electrode. In other cases, the method may utilize a plurality of stimulating electrodes and equal plurality of connector elements, and both the stimulating electrode and the connector element may comprise a ring conductor. Yet another aspect, the invention provides a system comprising any of the catheter structures described herein. The system may further include a pulse generator configured to deliver a high frequency current to at least one nerve stimulating electrode. The pulse generator is configured to deliver current at frequencies above about 4 kHz, amperage below about 15 mA, and voltages in the range of about 40 V to 60 V. In many cases, the pulse generator will be configured to deliver bipolar current to at least the first and second electrodes on the catheter body.

In the second aspect, embodiments of the present invention provide a system for controlling urination in a patient who has lost the ability to urinate due to an injury (eg, spinal cord injury), disease, or other cause. .. In one embodiment of such a system, an EUSS catheter or lead is coupled to a controller to control one or more aspects of the delivery of current to the EUS and sacral nerves by the EUSS catheter. The controller may accommodate one or more of the microprocessors or other logical resources that are either digital or analog. It may include its own power source, such as a chemical storage battery, or may be configured to be coupled to a power source, such as a battery or AC source.

The controller may also include, or be operably coupled with, a pulse generator or other electrical stimulator to generate various current waveforms to elicit one or more physiological responses involved in the urination process. good. Embodiments of such a system deliver electrical waveforms to nerves adjacent to or within the patient's EUS and stimulate nerve impulses that proceed to the patient's EUS so as to trigger the physiological effects involved in the micturition process. And / or configured to block. Such effects may include one or more of the patient's urethral opening, bladder contraction, and bladder relaxation. Specific properties of the waveform that may be selected to produce such an effect include one or more of frequency, voltage, current, and the like. However, typically frequency is a property used to produce a specific physiological effect. For example, high frequencies (such as in the range of 4-25 kHz, above 4 kHz, with a preferred value of about 5 or 6 kHz) open the urethra by blocking signals from the pudendal nerves that keep the EUS closed. Lower frequencies are used to contract the bladder (eg, 10-50 Hz, with a preferred value of about 20 hz), while ultra-low frequencies can be used to cause the bladder. Used for relaxation (eg, 1-15 Hz, with a preferred value of about 5 Hz) to stop urination. The system also has electrodes that are positioned in electrical contact with the patient's sacral nerve to deliver current in the form of an electrical waveform to stimulate and contract or relax the patient's bladder. (SNS) may include or be combined with a catheter or lead.

In a specific embodiment, the controller uses frequencies as described above to block signals from the pudendal nerves, open the urethral sphincter muscles, and allow urine to flow through the urethra. , Configured to deliver current to the EUS in the form of high frequency electrical waveforms. The controller also uses frequencies as described above to deliver a low frequency current to the sacral nerve to cause bladder contraction, to cause bladder relaxation and to stop urination. It may be configured to deliver low frequencies. In many embodiments, the controller is configured to deliver low and high frequency waveforms that start and end at the same time, typically at about the same time. However, other embodiments may first initiate a high frequency waveform to open the urethral sphincter and then initiate urination after a selected time cycle (eg, 0.5-5 seconds). In addition, it is assumed that a low frequency waveform for contracting the bladder is delivered in parallel.

Desirably, the amperage for one or more of the three waveforms (eg, high, low, and ultra-low frequencies described above) is below about 15 mA, more preferably below about 4 mA. The voltage is in the range of about 40V to 60V. The controller / pulse generator will typically be configured to deliver bipolar current to one or more electrode pairs on an EUS or SNS catheter, but in other cases it will deliver monopolar current. Can be configured as The controller is also configured to limit the total amount of electrical energy / power delivered so that it remains below what would injure, burn, or damage the tissue in the vicinity of the nerve stimulation electrode. Can be done. To that end, in certain embodiments, the controller receives an input from a temperature or other sensor located on the proximal end of the catheter and uses that input to injure or otherwise damage tissue near the catheter tip. It may be configured to control or otherwise regulate the delivery of electrical energy to the electrodes so that it remains below the selected temperature threshold that will cause it to remain below. In these and related embodiments, the controller may include temperature control algorithms such as P, PI, or PID algorithms, or equivalents as known in the art. Typically, the control algorithm will be implemented using a set of electronic instructions embedded within a processor or other logical resource embedded within the controller.

The system will also typically include implantable sensors configured to sense information corresponding to the filling or filling of the patient's bladder. Such implantable sensors will typically correspond to pressure or force sensors configured to measure or sense bladder pressure or filling. The sensor is operatively coupled to the controller to provide information about bladder filling, which in turn determines when urination should begin and stimulates one or both of the EUS and sacral nerves. May be used by the controller.

In a third aspect, embodiments of the present invention stimulate and open the EUS in a patient who has lost the ability to urinate spontaneously and allow the passage of urine through a nerve stimulating catheter within the patient's urinary tissue. , Leads, or other devices (such as any of the EUSS catheter embodiments described elsewhere herein). The method comprises providing a guided catheter and an EUSS catheter configured to be advanced into the patient's urethra. The inductive catheter comprises at least one lumen for advancing the EUSS catheter.

In many embodiments, the inductive catheter comprises two or three arm adapters at its proximal end, one arm of the adapter connected to the lumen for advancing the EUSS catheter lumen and a second. An arm is connected to a lumen for introducing liquid or gas to inflate the bladder mooring balloon described elsewhere herein, and a third arm allows fluid to pass in and out of the bladder. May be connected to the lumen for. According to some embodiments, the induction catheter lumen through which the USES catheter is advanced extends continuously from the adapter to the distal end of the induction catheter. In another embodiment, the inducible catheter lumen through which the EUSS catheter is advanced exits from the side of the inducible catheter, typically at a location proximal to the distal tip by a selected distance of 1 cm to 15 cm. , Terminate at a lateral deflection port or opening. In such and related embodiments, the inducible catheter can include an inflatable mooring balloon or other mooring means that surrounds the distal portion of the inductive catheter. The activation of the mooring means, typically the inflating of the mooring balloon, moored the distal portion of the induction catheter within the bladder. The exit opening (also referred to as the exit opening) of the EUSS catheter was chosen so that it closely aligns with the portion of the urethra in the vicinity of the EUS when the induction catheter is moored in the bladder. Placed proximal to the mooring balloon by distance. That is, the balloon or other anchor is positioned within the bladder so that the exit opening is consistent with the division of the urethra containing EUS. In some embodiments, the inductive catheter can be manually manipulated by a physician to facilitate the desired alignment. After the EUSS catheter or other EUSS device is advanced through the induction catheter and placed in or adjacent to the tissue of the urethral wall, the anchor is disengaged (eg, by degassing) and the induction catheter is removed from the urethra. It may be removed. As described below, according to some embodiments, removal may be facilitated by the use of radiodensity or other medical imaging markings.

The induction catheter is advanced into the urethra by a selected distance so that the distal end is in the vicinity of the portion of the urethra surrounded by the EUS. This may be facilitated by the placement of radiodensity or other markings on the induction catheter to visualize its location under fluoroscopy or other medical imaging modality. The EUSS catheter is then advanced through the lumen of the induction catheter until the distal tether portion exits and the tissue penetrating end of the distal tether portion of the catheter penetrates the urethra into the tissue adjacent to the EUS. To. The distal tether portion is typically pushed forward by pushing the proximal portion of the EUSS catheter until the distal tip exits through external tissue within the perineal area of the patient's body. Positioning is preferably (but not necessarily) performed using a medical imaging modality such as ultrasound or fluoroscopy to visualize the location of the stimulating and inducing catheters. For embodiments in which the inductive catheter has a mooring balloon and an opening in which it is placed proximally, the distal portion of the inductive catheter is advanced into the bladder and the mooring balloon is inflated to moor the inductive catheter into the bladder. (This can be pulled back slightly once the balloon is inflated). The EUSS catheter is then advanced out of the opening and thus the tissue penetrating tip through the urethral wall and into the EUS or surrounding tissue once the induction catheter is moored.

With respect to any of the above approaches (eg, moored and non-tethered induction catheters), the distal tether of the EUSS catheter is then indwelled with the ball tip or other mooring element in the tissue within the urethral wall or its adjacent tissue. Until, and multiple stimulating electrodes are located in the tissue adjacent to the EUS, typically within the perineal area so that the stimulating current is delivered through the electrodes to directly stimulate the EUS. At the location, it is pulled out of the patient's body. Also, in some embodiments, the physician will remove the distal tether portion of the EUSS catheter from the perineal area when the proximal anchor is placed in or adjacent to the tissue of the urethral wall. The resistance to pulling in may be tactilely sensed. This may be done by hand or using a force meter or other force measuring instrument known in the medical art. When used, such an approach is advantageous in that the tissue within the urethral wall or its adjacent tissue so that the ball tip or other mooring element remains fixed over a long time cycle, eg, years. Provides a more reliable approach to assessing proper detention within.

The exposed portion of the EUSS catheter is then pulled out of the tissue and then tunneled beneath the tissue within the patient's buttocks and / or back area, with the distal end being the selected tissue site, typically. May be advanced out of a tissue recess formed within the patient's back, abdominal area, or chest area. Such advancement is typically facilitated by the use of tunneling tools that can be customized (eg, in dimensions and shape) for use with embodiments of EUSS catheters. The tissue-penetrating distal portion of the lead catheter is then removed from the connector portion of the lead catheter, leaving a free connector end for connection to an implantable device such as a pulse generator and / or other wire. Removal can be accomplished by pulling and / or cutting the distal end of tissue penetration. The connector at the distal end of the catheter body is then electrically connected to a wire that makes an electrical connection to the pulse generator (or other embedded signal generator) and / or the pulse generator or other electrical stimulator. To. Connections can be performed using a variety of connecting means and methods known in the art, including, for example, snap-fitting, crimping, or other similar connecting means. After the connector is connected to the controller, the integrity of the connection sends a test signal from the controller or similar device to the EUSS catheter and observes or otherwise determines if there is relaxation of the patient's external urethral sphincter. Can be tested by doing.

After implantation of the EUSS catheter, a second stimulating catheter and / or lead is optionally implanted in the tissue, the electrodes of which are located on or near the sacral nerve, and the proximal portion of the catheter. , Can be connected to a pulse generator. The second stimulating catheter, known as a sacral nerve stimulating catheter or SNS catheter, can be used to stimulate the sacral nerve and cause bladder contraction due to the excretion of urine from the bladder. In one or more embodiments, the SNS catheter stimulates nerves and / or tissue, i) relaxes the EUS to open the patient's urethra and allow urine passage, ii) urinate from the bladder. Used in combination with an EUSS catheter to initiate and control urination in a patient by causing bladder contraction, iii) bladder relaxation, and iv) EUS contraction to close the patient's urethra. Can be. Similar to the EUSS catheter test, after connecting the SNS catheter to the pulse generator (or other electrical stimulator), the completeness of the connection sends the test signal from the pulse generator to the sacral nerve and the bladder contracts. It can be tested by observing or otherwise determining whether it has done so. Also, after implantation of the catheter, the incision in the patient's buttock or back used for the placement of the EUSS and SS catheters can be closed by suturing or other closing methods known in surgical techniques.

In a fourth aspect, embodiments of the invention provide a method for initiating and controlling urination in a patient with impaired bladder function (eg, due to a neurogenic bladder), the external urethral sphincter muscle. Is directly stimulated using the EUSS catheter or lead or device embodiment described herein to open the EUS for the passage of urine. Desirably, the electrical stimulus has a frequency in the range of about 4 kHz to 30 kHz, more preferably in the range of about 4 to 25 kHz, and even more preferably in the range of about 5 to 6 kHz. This stimulus is then complemented by electrical stimulation of the sacral nerve to cause bladder contraction and subsequent relaxation, releasing urine from the bladder, initiating urination, and then stopping once the bladder is empty. Can be done. Low frequency currents can be used to stimulate the sacral nerves to cause bladder contraction or relaxation, and ultra-low frequency currents are used to cause bladder relaxation and stop urination. Can be done. The low frequency current is in the range of about 10 Hz to 50 Hz and may have a frequency with a preferred value of about 20 Hz. The ultra-low frequencies used to relax the bladder are in the range of about 1 Hz to 15 Hz, more preferably in the range of about 4 to 6 Hz, and may be accompanied by a preferred value of about 5 Hz. Such sacral nerve stimulation has electrodes that are positioned in electrical contact with the patient's sacral nerve to deliver current in the form of an electrical waveform to stimulate the patient's bladder and contract or relax. It may be performed using a sacral nerve stimulation (SNS) catheter or lead.

For a more complete understanding of the nature and advantages of the invention, the following detailed description envisioned in conjunction with the accompanying drawings should be referred to. The drawings represent embodiments of the invention as an example. Therefore, the drawings and description of these embodiments are exemplary in nature and not restrictive.

FIG. 1A illustrates an embodiment of an external urethral sphincter stimulation (EUSS) catheter constructed according to the principles of the present invention.

FIG. 1B is a detailed view of the proximal portion of the EUSS catheter of FIG. 1A, including the nerve stimulation electrodes and mooring elements shown in the partial cross section.

FIG. 1C is a detailed view of the distal tip of the removable distal portion of the EUSS catheter obtained at line 1C-1C of FIG. 1A.

FIG. 2A illustrates a guidance catheter to be used with the EUSS catheter of FIG. 1A-1D as part of a urinary tract stimulation system for the placement of an EUSS catheter in the urinary tract according to an embodiment of the invention.

FIG. 2B is a cross-sectional view obtained along line 2A-2A of FIG. 2A.

FIG. 3A shows a guided catheter advanced in the male urethra, where the mooring balloon is inflated in the bladder and the removable distal portion (or distal tether portion) of the EUSS catheter is advanced through the external urethral sphincter muscle. Is illustrated.

FIG. 3B illustrates the removable distal portion of the EUSS catheter that is further advanced through the tissue, beyond the external urethral sphincter, to the remote area where the pulse generator should be implanted.

FIG. 3C is an enlarged view of the EUSS catheter at the final implantation position connected to the implantation pulse generator.

Various embodiments of the invention provide devices, systems, and methods for initiating and controlling urination in a patient who has lost the ability to urinate spontaneously due to a neurogenic bladder or other related condition. offer. Many embodiments provide devices, systems, and methods for electrical stimulation of the urethra, including direct stimulation of the external urethral sphincter (EUS) and bladder to initiate and control urination. Certain embodiments use catheters, leads, or other devices and urethral approaches to stimulate the EUS and bladder to initiate and control urination and lead within or adjacent to such tissue. Provides a system and method for positioning. When used, such embodiments are novel lows for positioning stimulation leads to control urination in patients lacking such control, while minimizing the risks and complications from invasive surgery. Provide invasive devices and methods. A related embodiment provides a method for positioning such a catheter or lead adjacent to the EUS, sacral nerve, or other location within the patient's body to initiate and / or control urination. .. As used herein, the term "about" means within ± 10% of the properties, dimensions, or other values described, more preferably within ± 5% of the values described. Also, as used herein, the term "substantially" means within ± 10% of the properties or qualities described and, where appropriate, within a numerical value of the properties or qualities described. , More preferably, within ± 5% of the properties or qualities described. With respect to qualitative properties or qualities such as pain or injury, "substantial" means less than what is clearly and repeatedly perceptible by the patient or medical professional.

Here, with reference to FIGS. 1A-C, an exemplary embodiment of the EUSS catheter constructed according to the principles of the invention typically has a proximal end and a distal end 21 and 22, respectively. It will comprise a body 12 (distal end 22 is also referred to and / or also includes distal tip 22). At its distal end, the catheter body is removably connected to the distal portion 14, also referred to as the distal tether 14 or tether 14. The catheter body 12 includes a proximal anchor 16 (also referred to as an anchor element 16) at its proximal end 21 and a plurality of stimulation electrodes 18 just distal to the proximal anchor 16. The catheter body 12 also typically includes a plurality of electrical connectors 20 in the distal portion of the catheter body that are operably coupled to the stimulation electrode 18, as described below. The catheter body 12 allows it to be advanced and followed through the induction catheter and then pulled by the distal portion 14 through the tissue so that the anchor 16 is placed in a selected tissue location such as EUS. It may be configured to have various properties known in catheter technology (eg, pushability, followability, etc.). Such properties can be achieved by selecting one or both of the dimensions and materials of the catheter body 12. In various embodiments, the catheter body 12 contains a variety of stretchability known in catheter techniques, including polyethylene (eg, HDPE, LDPE), PET, PEBAX, PTFE, and one or more of copolymers thereof. It can be processed from polymer. In addition, one or more of the aforementioned polymers may have increased stiffness, flexure, tension, compression, or torsional strength, or other desired mechanical properties (eg, electron beam). It may be irradiated (via). In some embodiments, the catheter body 12 is adjacent or adjacent so that compression of the tissue surrounding the catheter or the skin above it causes little or virtually no pain or discomfort to the patient. It can be configured to have compressibility or hardness similar to or less than that of the underlying tissue (eg, muscle or skin). Therefore, in these and related embodiments, the catheter body 12 and / or the material selected for its construction has a Shore A hardness in the range of 30-90, more preferably in the range of about 50-90. Can have.

The anchor 16 will typically have a spherical, enlarged valve, or other round shape, but various embodiments include wedge or conical shapes, pyramid shapes, and equivalents. , Other shapes are assumed in the same way. It can be processed from rigid or semi-rigid materials, including metals such as stainless steel (eg 304v stainless steel) and rigid polymers including, for example, polycarbonate, acrylic, polyether ketone (PEK). All or part of the anchor 16 may be conductive so as to deliver one or more stimulation currents as described herein. Therefore, in such an embodiment, the anchor 16 may be processed from various conductive metals and / or conductive polymers known in the art. In various embodiments, the anchor 16 may be structured or include various features to enhance one or more of its mooring capacity, long-term biocompatibility, and conductivity. .. For example, in one or more embodiments, the anchor 16 is a drug-eluting coating or other surface layer configured to reduce the attachment of cells, platelets, or proteins (eg, collagen) to the surface of the anchor 16. It may contain 16c. The anchor 16 may also include a surface layer or coating configured to reduce the deposition and / or precipitation of minerals in the urine on the anchor surface. Such layers or coatings may correspond to PTFE or other perfluoropolymers known in biomaterials and / or polymer techniques. In an additional or alternative embodiment, when the anchor 16 is also placed in or adjacent to the external urethral sphincter or EUS, it contracts around the urethra to prevent urine flow, or the urethra opens. It can be configured so as not to significantly interfere with functions, including the ability of the EUS to relax to allow it to. This can be accomplished by selecting one or more of the sizes and shapes of the anchor 16. In certain implementations to achieve such a function, the anchor 16 can have a spherical or spherical-like shape, such as an oval. Also, the volume of the anchor 16 can be selected to be less than the selected percentage of the total volume of the EUS. In various embodiments, the volume of the anchor 16 is less than about 25% of that of the EUS, more preferably less than about 20%, still more preferably less than about 10%, and even more so. Preferably, it can be kept below about 5%. In use, such embodiments include long-term implantation of a catheter 10 for initiation and control of micturition in a patient without impairing the function of the EUS, including its function in controlling micturition and maintaining micturition inhibition in the patient. Provides the benefits that enable. Also, in a specific implementation, the size of the patient's EUS can be pre-determined using medical imaging (eg, endoscopic ultrasonography) or by other means, and then the anchor 16 is of the EUS volume. It can be custom machined for a determined volume of EUS so that it remains below the selected percentage.

A discussion of the connector 20 will be presented here. The connector 20 (also referred to as an electrical connector 20) is configured to electrically couple the stimulation electrode 20 to a pulse generator such as a pulse generator 70, and is positioned at various locations along the catheter body 12. May be good. In various embodiments, the connector 20 may include a series of conductive elements such as conductive metal rings or strips that are located on or otherwise coupled to the catheter body 12. According to one or more embodiments, a plurality of connectors 20, typically equal to the number of stimulating electrodes 18, are distal to the catheter body 12 immediately proximal to the proximal end of the distal tether 14. It may be located at or near the end 22. However, other positions with respect to the connector 20 closer to the electrode 18 are also envisioned. In certain embodiments, each stimulating electrode 18 is electrically coupled to the corresponding connector 20 by a single insulating wire or other conductor 26, typically located within the inner lumen 28 of the catheter body 12. Will be done. Optionally, a high-strength polymer filament such as an aramid (kebra) filament or other elongation reinforcing element 30 connects the proximal anchor 16 to the distal end 22 of the catheter body 12 and the catheter is pulled through the tissue by the distal tether 14. It can be provided to provide enhanced tensile strength of the catheter that allows it to be. Other reinforcing elements may include one or more of rigid polymer members, hardened wires, or braided compartments. As will be described in more detail below, the catheter body 12 is implanted by pulling the distal tether 14 distally, which exerts significant axial stress on the catheter body. The use of the reinforcing element 30 provides the advantage of enhancing the dimensional stability of the catheter body when exposed to such stresses. In addition, the use of aramid filaments or other reinforcing elements 30 not only allows the catheter 10 / catheter body 12 to be pulled through the tissue by the distal tether 14, but also EUS or other options. It also provides the advantage of making it possible to do so with sufficient force to moor the proximal anchor 16 at the tissue site. For example, in certain embodiments where the catheter body 10 comprises a reinforcing element 30, the catheter 10 is 0.5-10 pounds relative to the anchor 16 by pulling on the distal tether 14 or distal portion of the catheter 10. Can be configured to allow the transmission of the force of.

The distal tether 14 may comprise one or more of a polymer member such as a wire, a polymer fiber, or a polymer coated wire such as a polyimide coated wire. In certain embodiments, the distal tether 14 has sufficient column strength to be pushed from its proximal end through the tissue and sufficient tension to be pulled from its distal end and pull the catheter body 12 through the tissue. It is equipped with a stretchable metal wire such as a nickel-titanium alloy with strength. The distal tip 24 of the distal tether 14 can be sharpened or otherwise configured to penetrate the tissue as the tether is advanced distally through the tissue. In some embodiments, although not shown, the distal end of the tether 14 is steerable to allow the physician to guide the tether 14 when it is being pushed through the tissue. There may be. Steerability can be implemented using a variety of techniques known in the art, including the use of traction wires, fluid engineering (including computer-controlled microfluidic pressure), piezoelectric materials, and shape memory materials. can.

The stimulating electrode 18 is configured to stimulate the EUS and block signals from the pudendal nerve to relax the EUS and is positioned on the catheter body 12. The specific number and spacing of the stimulation electrodes 18 on the catheter 12 is configured to generate a selectable electric field volume within or adjacent to the EUS to stimulate and relax the EUS in response to energization of the stimulation electrodes. Can be done. In a related embodiment, the number of electrodes energized with an electric current to stimulate the EUS can also be selected to generate the desired electric field volume within or adjacent to the EUS.

As illustrated in FIGS. 1A-1C, the stimulating electrode is a ring electrode 18 embedded in the outer surface of the catheter body 12 and is positioned close to the anchor 16. Other shapes for the electrode 18 are also envisioned, including a semi-ring (which extends around half the circumference of the catheter body), a circle, an oval, and a strip that extends along the axial length of the catheter. Will be done.

In various embodiments, the stimulating electrode 18 is a conductive patch that is radially spaced apart in various configurations, eg, two electrodes separated by about 180 °, three electrodes separated by about 60 °, about 45 °. It may correspond to four electrodes separated from each other. The specific spacing can be configured to generate a selected electric field volume within or surrounding the EUS. These electrodes may be configured as bipolar or monopolar electrodes. In the latter case, the catheter tip 22 may also include a reference electrode or an external return electrode as described herein. In the former case, the radially separated electrodes are 180 ° radially separated from a pair of radially separated bipolar electrodes, eg, the first pair on one side of the catheter tip and the first pair. It may correspond to the second pair. Also, in various embodiments, the electrodes may be positioned on the surface of the catheter body 12, or an amount selected to control the depth of penetration of the current into the tissue, eg, about 0. Only .0001 inches to about 0.01 inches (0.001 inches and 0.005 inches in specific embodiments) may be embedded beneath the surface. A larger amount of depression generally reduces the depth of current penetration into the tissue and thus reduces any resulting heating.

As shown in FIGS. 2A and 2B, the induction catheter 40 used to advance the catheter 10 in the patient's urinary tract has a hub 44 at its proximal end and an inflatable balloon 46 at its distal end 48. The extension shaft 42 is provided. As shown in FIG. 3A, the balloon is configured to anchor in the patient's bladder B just above the opening to the urethra U when inflated. The shaft is typically a multi-lumen extrude comprising a lumen 50 configured to receive the EUSS catheter 10 as described above and an inflated lumen 52. Optionally, the shaft may further include a lumen 54 for access to the bladder. The EUSS catheter lumen 50 is accessible through port 56 at the hub 44 and terminates at exit port 62 through the sidewall of the shaft. The exit port 62 is axially on the shaft 42 so that the exit port is located near the patient's external urethral sphincter EUS when the balloon is inflated and positioned within the bladder, as shown in FIG. 3A. Positioned in. The inflatable lumen connects to the inflatable port 58 at the hub at the proximal end of the lumen and to the balloon 46 at the distal end of the lumen. The access lumen 54 connects through the access port 60 in the hub 44 and typically extends completely to the distal end 48 of the shaft and is a port formed at the distal tip (hidden in FIG. 2A). ) To open.

Here, with particular reference to FIG. 3A-3C, when performing an implantation procedure according to the principles of the present invention, the induction catheter 40 has a balloon 46 positioned in the bladder where it is inflated in the bladder. Is advanced through the patient's urethra U. The physician then retracts the EUSS catheter 10 proximally (away from the bladder B) and seats an inflated balloon 46 at the bottom of the bladder above the opening of the urethra U, as shown in FIG. 3A. .. In this position, the exit port 62 will be located in or within the external urethral sphincter EUS.

After the induction catheter 40 is properly positioned with the external urethral sphincter EUS or the exit port 62 therein, the distal tether 14 of the EUS catheter 10 has a tissue penetrating tip outward, as shown by the dashed line in FIG. 3A. The urethral sphincter muscle will be advanced into and through the tissue within or adjacent to the EUS. Such advancement is typically achieved by staying outside the induction catheter and manually pushing a portion of the EUS catheter 10 available for manual operation. Of course, it should be understood that such advances can also be achieved using surgical robots or other automated systems. Various embodiments of the invention specifically envision the use of elements or other features on the EUS catheter 10 to allow forward and other manipulations by surgical robots.

Now referring to FIG. 3B, the distal tether 14 is advanced until it appears through the patient's skin, typically through the patient's perineal PP, where it is grasped and the entire catheter 10. However, as shown in FIG. 3C, the anchor 16 can be pulled distally until it engages and sits in the tissue in or near the external urethral sphincter EUS. It should be noted that the induction catheter is not shown in FIG. 3B (to reduce complexity), but will still be in place during the actual procedure. After the proximal anchor 16 is properly positioned with respect to the external urethral sphincter EUS, the induction catheter 40 may then be removed, or if continued access to the bladder B is desired. It may be left in place.

Here, referring to FIG. 3C, once the proximal anchor 16 is located in the external urethral sphincter EUS, the connector 20 may be external, but more often in the tissue recess formed in the back of the patient. Will be positioned to connect to a pulse generator 70 (shown in FIG. 3C), which will be embedded in. The connector is a meeting of patients by tunneling or other conventional surgical techniques known in the art and / or including various minimally invasive techniques as described elsewhere herein. It may be advanced from the Yin P to the pulse-generating implant site.

As described herein, various embodiments of the invention deliver electrical energy into the tissue of the EUS to block signals from nerves that innervate the EUS (eg, urethral nerves). Doing so without causing pain or injury to the patient, including damage to one or more of the EUS, urethra, or pudendal nerve (eg, fever, electricity, or other). Suppose. This can be accomplished through a variety of means, including controlling the characteristics of the electrical energy delivered, including, for example, current, frequency, and voltage. This can also be achieved by controlling the shape and area of the electrodes or other energy delivery elements. For example, in the specific embodiment, the area of each electrode is about 0.1 mm to about 100 mm, and in the specific embodiment, 0.5, 1, 2.5, 5, 10, 20, 25, 50, 75, And can reach 80 mm. Larger areas can be used to reduce the current density at a given electrode and thus the degree of ohm heating of the tissue. Shapes with respect to the electrodes that can be employed to reduce pain or injury from ohm heating include circular, oval, or rectangular with round edges (eg, due to the edge effect from higher current densities). Includes those with round edges. Specific embodiments of the invention provide an inventory of electrodes or other energy delivery elements for the EUS stimulation catheter described herein, with different areas and shapes (eg, circular, oval, etc.). , Urethral and urethral sphincter US and are selected to reduce pain and injury to surrounding tissues including the pudendal nerve. According to one or more embodiments, electrodes 18 and the like having the selected size and shape are known on the distal portion of the catheter (eg, snap fit or press fit or catheter technology), including the distal end 22 of the catheter. It can be configured to fit removable (by other means). Once fitted, the doctor then advances the catheter into the urethra to determine if the electrodes cause any pain in the patient and their intended function (eg, causing relaxation of the EUS). Several test deliveries of electrical energy can be performed to determine whether to perform. Alternatively, the electrode size and shape are based on patient parameters such as profile, weight, age, medical conditions, etc., especially for a population of those patients who have those characteristics, especially the electrode characteristics (eg, area,). Shapes, and materials) can be selected for patient populations that do not cause pain or injury to the patient from ohm heating.

According to one or more embodiments, the controller 50 also delivers electrical energy such that it remains below what would injure, burn, or damage tissue near the catheter tip, including the pudendal nerve. / Can be configured to limit the total amount of power. To that end, in certain embodiments, the controller 50 receives an input from a temperature or other sensor 41 located on or near the catheter tip 40 and uses that input to injure or injure tissue in the vicinity of the catheter tip. It may be configured to control or otherwise regulate the delivery of electrical energy to the electrodes so that it remains below the selected temperature threshold that would otherwise damage it. In these and related embodiments, the controller may include temperature control algorithms known in the art such as P, PI, or PID, or other similar control algorithms. Such an algorithm can be implemented via a set of electronic instructions embedded within the controller 50 or otherwise embedded within a processor or other logical resource that communicates with it.

The above description of the various embodiments of the invention are presented for purposes of illustration and illustration. It is not intended to limit the invention to the disclosed precise forms. Many modifications, variations, and refinements of the embodiments described herein will be apparent to those of skill in the art, including those of skill in the art in medical implants, sensors, neurostimulation, and urinary device techniques. Let's do it. For example, embodiments of the device can be sized and otherwise adapted for a variety of pediatric and neonatal applications and a variety of veterinary applications. They may also be adapted for the urinary tract of both male and female patients. In addition, one of ordinary skill in the art will be able to recognize or confirm a number of equivalents of the specific devices and methods described herein using experiments that are only routine. Such equivalents are considered to be within the scope of the invention and are covered by the appended claims below.

With respect to drawings, it should be understood that drawings are not always drawn to scale. There are also differences between the imaginary and actual equipment shown in the drawings due to the perspective of the drawings, drawings that are not necessarily to scale, size constraints, manufacturing considerations, and other factors. obtain. Also, there are multiple embodiments and / or elements of embodiments that are not necessarily shown in the drawings, which are nevertheless envisioned by the present disclosure.

Moreover, elements, properties, or acts from one embodiment can easily be combined with one or more properties or acts from another embodiment in order to form a number of additional embodiments within the scope of the invention. It can be recombined or substituted. Moreover, the elements shown or described as being combined with other elements can exist as independent elements in various embodiments. Also, with respect to any positive enumeration of elements, properties, constructs, features, steps, etc., embodiments of the present invention specifically assume exclusion of the elements, values, properties, constructs, features, or steps. .. Accordingly, the scope of the invention is not limited to the details of the embodiments, examples, and drawings described, but instead is limited only by the appended claims.

According to one or more embodiments, the controller 50 also delivers electrical energy such that it remains below what would injure, burn, or damage tissue near the catheter tip, including the pudendal nerve. / Can be configured to limit the total amount of power. To that end, in certain embodiments, the controller 50 receives an input from a temperature or other sensor 41 located on or near the proximal catheter end 21 and uses that input to capture tissue in the vicinity of the catheter tip. It may be configured to control or otherwise regulate the delivery of electrical energy to the electrodes so that it remains below the selected temperature threshold that will cause injury or otherwise damage. In these and related embodiments, the controller may include temperature control algorithms known in the art such as P, PI, or PID, or other similar control algorithms. Such an algorithm can be implemented via a set of electronic instructions embedded within the controller 50 or otherwise embedded within a processor or other logical resource that communicates with it.

Claims (44)

A method for positioning an external urethral sphincter stimulation (EUSS) catheter within a patient's urinary tissue.
Positioning the induction catheter within the patient's urethra so that the exit port of the induction catheter is near the patient's external urethral sphincter.
The guide so that the tissue penetrating end of the distal portion of the catheter penetrates the urethra into the tissue adjacent to the external urethral sphincter and exits the tissue out into the patient's perineum. To advance the EUSS catheter through the lumen of the catheter,
From the perineal area to the EUSS catheter until the proximal anchor is placed in or adjacent to the tissue of the urethral wall so that one or more electrodes are located near the external urethral sphincter. Pulling in the distal part and
Tunneling the distal tether portion from the EUSS catheter to a location within the patient's buttocks and / or back area so that the connector on the EUSS catheter is located at the connection location.
A method comprising disconnecting the distal portion from the EUSS catheter and leaving the connector at the connection location. The method of claim 1, further comprising connecting the connector of the EUSS catheter to a pulse generator. The method of claim 1, further comprising embedding the pulse generator in a tissue recess at the connection location. The method of claim 3, wherein the pulse generator is implanted within the back area of the patient. The method of claim 1, wherein the pulse generator is external. Tactile sensing of resistance to retracting the distal tether portion of the EUSS catheter from the perineal area when the proximal anchor is placed in or adjacent to the tissue of the urethral wall. The method of claim 1, further comprising: The method of claim 1, wherein the four electrodes are located near the external urethral sphincter. The method of claim 1, wherein the one or more electrodes are located within or on the surface of the external urethral sphincter. Sending a stimulus signal through one or more of the electrodes,
The method of claim 1, further comprising confirming the proper positioning of the one or more electrodes by determining the response of the EUS to the stimulus signal. 9. The method of claim 9, further comprising repositioning the EUSS catheter if the EUS does not respond to the stimulus signal as expected. 10. The method of claim 10, further comprising immobilizing the EUSS catheter in place if the EUS reliably responds to the stimulus signal as expected. The method of claim 1, further comprising mooring the distal portion of the induction catheter within the bladder of the patient while performing the other steps of the method. 12. The method of claim 12, wherein the induction catheter is moored using a mooring device. 13. The method of claim 13, wherein the mooring device is an inflatable balloon. 12. The proximal anchor on the EUSS catheter further comprises disengaging and removing the induction catheter from the urethra after being placed in or adjacent to the tissue of the urethral wall. The method described. A method for positioning an external urethral sphincter stimulation (EUSS) device within a patient's urinary tissue.
Positioning the induction catheter within the patient's urethra so that the exit port of the induction catheter is near the patient's external urethral sphincter.
The guide so that the tissue penetrating end of the distal portion of the device penetrates the urethra into the tissue adjacent to the external urethral sphincter and exits the tissue out into the patient's perineum. To advance the EUSS device through the lumen of the catheter,
From the perineal area to the EUSS device until the proximal anchor is placed in or adjacent to the tissue of the urethral wall so that one or more electrodes are located near the external urethral sphincter. Pulling in the distal part and
Tunneling the distal tether portion from the EUSS device to a location within the patient's buttocks and / or back area so that the connector on the EUSS device is located at the connection location.
A method comprising disconnecting the distal portion from the EUSS device and leaving the connector at the connection location. 12. The method of claim 12, wherein the EUSS device comprises a catheter. A method for treating the initiation and / or control of urination in a patient with a neurogenic bladder, said method.
By locating at least one stimulating electrode within the patient's external urethral sphincter (EUS), the at least one stimulating electrode is anchored within the EUS using an anchor and the anchor is at least partially. , Positioned within the EUS and operably coupled to the at least one stimulating electrode.
Using the at least one stimulating electrode, a high frequency current is delivered to the EUS, blocking signals from the patient's pudendal nerves, relaxing the EUS, and opening the patient's urethra for urine passage. Methods, including what to do. 18. The method of claim 18, wherein the at least one stimulating electrode and the anchor are placed on a catheter implanted in the patient. 18. The method of claim 18, wherein the at least one stimulating electrode comprises at least two stimulating electrodes. 18. The method of claim 18, wherein the high frequency current has a frequency in the range of about 4-25 kHz. 21. The method of claim 21, wherein the high frequency current has a frequency in the range of about 5-6 kHz. 18. The method of claim 18, wherein delivery of the high frequency current does not cause any substantial pain or injury to the patient. 18. The method of claim 18, further comprising delivering a low frequency current to the patient's sacral nerve or surrounding tissue to cause the patient's bladder to contract. 24. The method of claim 24, wherein the low frequency current is delivered by a sacral stimulation device or sacral stimulation catheter. 24. The method of claim 24, wherein the low frequency current has a frequency in the range of about 10-50 Hz. 24. The method of claim 24, further comprising delivering an ultra-low frequency current to the patient's sacral nerve or surrounding tissue to relax the patient's bladder. 27. The method of claim 27, wherein the ultra-low frequency current has a frequency in the range of about 10-15 Hz or a value of about 5 Hz. A catheter for electrical stimulation of the patient's external urethral sphincter (EUS), said catheter.
A catheter body having a distal end and a proximal end, wherein the catheter body is sized and configured for advancing through the lumen of the induction catheter.
A mooring element located at the proximal end of the catheter body, wherein the mooring element is configured to moor the proximal end within the patient's EUS or urethral wall.
At least one nerve stimulating electrode, said at least one nerve stimulating electrode, such that when the mooring element is moored within the EUS or urinary tract wall, the electrode is positioned within or near the EUS. Positioned near the proximal end of the catheter body, distal to the mooring element, the stimulating electrode delivers a high frequency current to the EUS, blocking signals from the patient's pudendal nerves. With at least one nerve stimulation electrode configured to relax the patient's EUS,
At least one connector element, said at least one connector element, located on the distal portion of the catheter body and electrically coupled to the at least one neurostimulating electrode, the conductor element being pulsed. With at least one connector element configured to connect to the vessel,
A distal tether that is removablely attached to the distal end of the catheter body, the distal tether is the urinary tract wall as the catheter body is advanced by pushing its proximal end. Has a tissue-penetrating distal tip for penetrating and exiting the tissue on the posterior part of the patient, the distal tether being pulled from the distal end to place the mooring element within the EUS or urinary tract wall. A catheter with a distal tether, configured to be indwelling. 29. The catheter of claim 29, wherein the at least one nerve stimulating electrode comprises at least two nerve stimulating electrodes. 30. The catheter of claim 30, wherein the at least two nerve stimulating electrodes are axially spaced along the length of the catheter body distal to the mooring element. 30. The catheter of claim 30, wherein the first nerve stimulating electrode is located on one side of the catheter body and the second nerve stimulating electrode is located on the opposite side of the catheter body. 29. The catheter of claim 29, wherein the at least one nerve stimulating electrode comprises at least three nerve electrodes. 29. The catheter of claim 29, wherein the at least one nerve stimulating electrode comprises at least four nerve electrodes. 29. The catheter of claim 29, wherein the mooring element has a ball shape with a diameter greater than the diameter of the proximal end of the catheter body. 29. The catheter of claim 29, wherein the mooring element is conductive and is configured to act as a nerve stimulating electrode. 29. The catheter comprises a plurality of stimulating electrodes and a plurality of equal connector elements, both the stimulating electrode and the connector element comprising a ring conductor embedded in the wall of the catheter body. Catheter. 29. The catheter of claim 29, wherein the catheter body has a hardness less than or equal to the hardness that causes the patient's pain or discomfort when the tissue adjacent to or above the catheter body is compressed. 38. The catheter according to claim 38, wherein the catheter body has a shore A hardness in the range of about 30-90. A system for initiating and / or controlling urination in a patient, said system.
The catheter according to claim 29 and
A system comprising a pulse generator configured to deliver a high frequency current to said at least one nerve stimulating electrode. 40. The system of claim 40, wherein the pulse generator is configured to deliver current at frequencies above 4 kHz, amperes below 15 mA, and voltages in the range of 40 V to 60 V. 40. The system of claim 40, wherein the pulse generator is configured to deliver bipolar current to at least the first and second electrodes on the catheter body. 40. The system of claim 40, further comprising an inducible catheter having an exit port positioned so as to be located close to the external urethral sphincter as the inducible catheter is advanced into the patient's urethra. A system for initiating and / or controlling urination in a patient, said system.
The catheter according to claim 29 and
A system comprising an inducible catheter having an exit port positioned so as to be located close to the external urethral sphincter as the inducible catheter is advanced into the patient's urethra.

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